I. NIMH DIRP CLINICAL SUPPORT SERVICES: The NIMH DIRP Office of the Clinical Director (OCD) coordinates a range of clinical, administrative, and research-related support services to the Institute and Scientific Director including: 1) administrative oversight of NIMH inpatient units and outpatient clinics through chart auditing, review of occurrence reports involving NIMH subjects, monthly performance improvement meetings and weekly meetings with clinical investigators and their staff to review the clinical status of protocol participants;2) the provision of emergency medical/psychiatric coverage to all NIMH research participants 24 hours/day, 7 days/week;3) credentialing of all members of the NIMH medical staff;and 4) education, training and monitoring of DHHS, NIH, NIMH DIRP, Clinical Center and other regulatory agencies'policies related to human subjects safeguards during the conduct of clinical research. The NIMH Clinical Director serves as a member of the Intramural Working Group and the NIH Work Group on Mental Health. II. HUMAN SUBJECTS PROTECTIONS ACTIVITIES INCLUDING SUPPORT OF THE CNS IRB: NIMH is one of six Institutes participating in the CNS IRB which reviews nearly 600 clinical research protocols (120 are NIMH protocols). The OCD provides administrative, regulatory, educational, ethical and scientific support to help investigators write and review protocols and to ensure human subjects protections (with patient subjects and healthy volunteers) from initial protocol submission through continuing annual reviews to study completion and publication. The NIMH Clinical Director reviews all NIMH DIRP protocols and serves as a member of the Committee for Scientific Review of Protocols (CSRP), the CNS IRB Steering Committee, the Human Subjects Research Advisory Committee (HSRAC), and the CC Medical Executive Committee (MEC). The Human Subjects Protections Unit (HSPU) is an award-winning team that was created to protect vulnerable human subjects participating in mental health research. The HSPU members, composed of advanced practice social workers and nurses, monitor the informed consent process (258 in FY09), perform decisionmaking capacity assessments for studies involving potentially impaired subjects (27 in FY09), perform assessments of surrogate understanding (8 in FY09) and assessments of a subject's ability to appoint a Durable Power of Attorney (5 in FY 09). HSPU members consult to investigators on human subjects protections issues on 57 protocols, and monitor all NIMH inpatient subjects (average daily census 20.5 in FY09). HSPU provides training and education of researchers in other NIH Institutes and has used their expertise to develop an informed consent training video for all NIH investigators. Since spring of this year, HSPU has worked collaboratively with the CC Bioethics Department to monitor the process of how vulnerable subjects and their families make decisions regarding research participation. The Marketing and Community Relations Unit (MCRU) is responsible for facilitating comprehensive and collaborative NIMH patient recruitment through design and materials development, targeted marketing and advertising planning, and community outreach. Services include creating branded and unified recruitment materials, websites, advertising schedules, event planning for investigators'presentations, and presentations to advocacy groups, school systems, and health care providers, among other services. MCRU also reviews and assists with material approvals to meet IRB guidelines. In FY09, our community outreach program made over 300 appointments with community groups and providers, including nine area providers groups, eight area school systems and specialty schools, 12 area hospitals, and others. In addition, investigators made 29 community outreach presentations, 22 information booths were exhibited at mental health fairs, and 3 evening events for the general public were held with over 100 attendees each time. III. TRAINING AND EDUCATION: The NIMH DIRP OCD, in conjunction with the NIMH Office of Fellowship Training, coordinates several training programs including a unique one-year research oriented American College of Graduate Medical Education (ACGME) accredited Post-Graduate Year (PGY)-4 psychiatry residency;clinical research fellowships in basic and translational laboratories;Psychosomatic Medicine Fellowship, a collaborative training program with Georgetown University Medical Center and the Washington Hospital Center;a joint clinical-research fellowship training program with Children's National Medical Center;and resident and medical student rotations. The OCD has actively supported the development and implementation of the CC Neuropsychiatry Nurse Fellowship Program and helped to develop a monthly seminar series on mental health aspects of nursing care of medical patients. The OCD is responsible for overseeing ongoing education in clinical training activities including the curriculum of trainees from high school students to postdoctoral fellows. The NIMH DIRP jointly sponsored with the NIMH Office of the Director, "Brain Camp" at Cold Spring Harbor, a focus group of leading neuroscientists and outstanding psychiatric residents nominated from leading US medical institutions, in an effort to develop a relevant clinical neuroscience curriculum to be implemented in psychiatric residencies. Current efforts at further development and implementation of the curriculum are underway. In addition, OCD staff members prepare and conduct training in protocol preparation, human subjects protection, and the conduct of informed consent with investigators and other NIMH DIRP research staff. IV. CC LIAISON ACTIVITIES: The NIMH DIRP OCD provides a variety of clinical support services to the CC and other Institutes including: 1) providing psychiatric consultation and liaison services to medically- and surgically-ill patient subjects enrolled in clinical research (more than 600 new psychiatric consultations to other Institutes in FY09);2) the provision of emergency medical/psychiatric coverage to all NIH research participants 24 hours/day, 7 days/week;3) the development of a new neuropsychological testing service for clinical and research information;4) providing education to members of the multidisciplinary teams caring for research participants in behavioral health related topics;5) participating in the CC Behavioral Health Units Partners working group in order to meet regulatory standards (i.e., Joint Commission for Accreditation of Hospital Organizations, Office of Human Subjects Research);and 6) providing consultation and expertise to the CC. V. RESEARCH IN PSYCHOSOMATIC MEDICINE (Psychiatric Consultation Liaison Service) strives to integrate rapidly evolving knowledge derived from basic neuroscience and molecular medicine with state-of-the art clinical care in order to better understand and treat psychiatric conditions in the medically- and surgically -ill. The NIMH DIRP OCD participates in multiple collaborative clinical research projects further described in MH002922-01.